Thermo Fisher Granted CE Mark for COVID-19 Test

Thermo Fisher Scientific is bringing its diagnostic detects nucleic acid from SARS-CoV-2, the virus that causes COVID-19, to Europe. The Waltham, MA-based company said earlier today it had received CE mark for the test. The test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab. The estimated time-to-result also includes time for sample preparation and instrument analysis. "The CE mark certification is an important step in combatting the outbreak of COVID-19 across Europe," said Marc Casper, chairman, president and CEO of Thermo Fisher Scientific. "We are committed to fighting this disease and we will continue to work with regulatory authorities and customers around the world to expand the availability of diagnostic testing and stem the spread of the coronavirus." Europe has become the epicenter for the COVID-19 the World Health Organization said. Italy’s death toll from the virus has been the highest – hitting about 7,503 people, according to www.worldometers.com. The website shows Italy has more than 74,000 patients that have been diagnosed with coronavirus and 9, 362 recovering. However, Italy’s number of new cases has declined for the fourth day in a row according to a report from CNBC. Thermo Fisher’s CE mark designation comes only a few short days after FDA granted Thermo Fisher Scientific Emergency Use A...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Regulatory and Compliance Source Type: news